Iec Tr 61010-3-101-2003.Pdf

TECHNICAL REPORT IEC TR 61010 3 101 First edition 2003 04 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 3 101 Conformity verification report for IEC[.]

REPORT TR 61010-3-101

First edition 2003-04

Safety requirements for electrical equipment

for measurement, control, and laboratory use –

Part 3-101:

Conformity verification report for

IEC 61010-2-101:2002 –

Particular requirements for in vitro

diagnostic (IVD) medical equipment

Règles de sécurité pour appareils électriques

de mesurage, de régulation et de laboratoire –

Partie 3-101:

Rapport de vérification de la conformité

de la CEI 61010-2-101:2002 –

Prescriptions particulières pour appareils médicaux

de diagnostic in vitro (DIV)

Reference numberIEC/TR 61010-3-101:2003(E)

60000 series For example, IEC 34-1 is now referred to as IEC 60034-1.

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REPORT TR 61010-3-101

First edition 2003-04

Safety requirements for electrical equipment

for measurement, control, and laboratory use –

Part 3-101:

Conformity verification report for

IEC 61010-2-101:2002 –

Particular requirements for in vitro

diagnostic (IVD) medical equipment

Règles de sécurité pour appareils électriques

de mesurage, de régulation et de laboratoire –

Partie 3-101:

Rapport de vérification de la conformité

de la CEI 61010-2-101:2002 –

Prescriptions particulières pour appareils médicaux

de diagnostic in vitro (DIV)

PRICE CODE

 IEC 2003  Copyright - all rights reserved

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mechanical, including photocopying and microfilm, without permission in writing from the publisher.

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Commission Electrotechnique Internationale

International Electrotechnical Commission

Международная Электротехническая Комиссия

FOREWORD 3

Conformity verification report for IEC 61010-2-101:2002 5

5 Marking and documentation 11

6 Protection against electric shock 15

7 Protection against mechanical HAZARDS 21

8 Mechanical resistance to shock and impact 21

9 Protection against the spread of fire 22

10 Equipment temperature limits and resistance to heat 23

11 Protection against HAZARDS from fluids 24

12 Protection against radiation, including laser sources, and against sonic and ultrasonic pressure 25

13 Protection against liberated gases, explosion and implosion 25

14 Components 26

15 Protection by interlocks 27

16 Test and measurement equipment 27

Annex F – Routine tests 27

Annex AA – RISK management .27

Annex BB – Instructions for use for self-test IVD medical equipment .27

Annex XX – List of applicable and omitted clauses/subclauses and associated forms in the test report 62

Annex YY – Details of the changes included in the combined CVR for TR IEC 61010-3-101:2003, to reflect the specific requirements of IEC 61010-2-101:2002 67

Table 1 – Documents reviewed 8

Table 2 – Test equipment list 9

Table 3 – List of components and circuits relied on for safety 10

Form A.1 to Form 33 28 to 61

INTERNATIONAL ELECTROTECHNICAL COMMISSION

_

SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT

FOR MEASUREMENT, CONTROL, AND LABORATORY USE –

Part 3-101: Conformity verification report for IEC 61010-2-101:2002

Particular requirements for in vitro diagnostic (IVD) medical equipment

FOREWORD

1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees) The object of the IEC is to promote

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The main task of IEC technical committees is to prepare International Standards However, a

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data of a different kind from that which is normally published as an International Standard, for

example “state of the art”.

IEC 61010-3-101, which is a technical report, has been prepared by IEC technical committee

66: Safety of measuring, control, and laboratory equipment.

The text of this technical report is based on the following documents:

Enquiry draft Report on voting66/279/DTR 66/317/RVC

Full information on the voting for the approval of this technical report can be found in the

report on voting indicated in the above table.

This publication has been drafted in accordance with the IEC/ISO Directives, Part 2.

This report is a Technical Report and is of a purely informative nature and is therefore by

itself not to be regarded as an International Standard It is to assist users of the standard with

determining and recording verification of conformity of the equipment under test with the

requirements of:

IEC 61010-2-101: 2002 The protocol for completion of this report is contained in publication IEC 61010-3:2003.

The IEC sells read-only PDF files as a general rule In the present instance, and quite

exceptionally, to enable the user to fill in the forms, a revisable file is included in a pocket

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and is subsequently converted to Word 6, some of the symbols may have been incorrectly

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converted document.

The committee has decided that the contents of this publication will remain unchanged until

2008 At this date, the publication will be

TEST REPORT IEC 61010-2-101 Safety requirements for electrical equipment for measurement,

control, and laboratory use Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipmemnt

Report Reference No :

Tested by (name and signature) : Approved by (name and signature) :

Date of issue :

Contents : Pages Testing organisation :

Address :

Testing location :

Applicant’s name :

Address :

Test specification: Standard : IEC 61010–2–101 : 2002 / and IEC 61010 – 1: 2001 (2nd Edition) Copyright blank test report :

Test Procedure :

Procedure deviation :

Non-standard test method :

This report has been prepared by IEC TC 66, which retains responsibility for any changes or corrections required Test item description :

Trademark :

Model/Type reference :

Rating(s) :

Test item particulars :

Type of item tested : Measurement / Control / Laboratory

Description of equipment function :

INSTALLATION/OVERVOLTAGE CATEGORY :

POLLUTION DEGREE :

Environmental rating : standard / extended (specify):

Equipment mobility : portable / hand-held / floorstanding / fixed / built in/

benchmounted/other (specify):

Connection to mains supply : Permanent / detachable cord set /

non detachable cord set / none Operating conditions : continuous / short-time / intermittent

Overall size of the equipment (L x W x H) :

Mass of the equipment (kg) :

Marked degree of protection to IEC 60529 : IP _ _

Accessories and detachable parts included in the

evaluation :

Options included :

Test case verdicts:

Test case does not apply to the test object : N/A

Test object does meet the requirement : P(Pass)

Test object does not meet the requirement : F(Fail)

General remarks:

The test results presented in this report relate only to the item(s) tested.

"(see remark #)" refers to a remark appended to the report.

"(see Annex #)" refers to an annex appended to the report.

"(see Form A.#)" refers to a table appended to the report.

Throughout this report a comma (point) is used as the decimal separator.

Copy of equipment markings :

Summary of test results (information/comments):

TABLE: 1 - Documents reviewed Document

Name

Yes / No

Page Numbers

TABLE: 2 - Test equipment list

Calibration date Test

equipment

number

Type and make

Unique identification number Last

note 1 Due

Ranges used note 2

Comments

Note 1 Or interval between calibrations

Note 2 Range used may by noted using the Instrument Code on the specific Form

NOTE 1 - List all manufacturers concerned.

NOTE 2 - Electrical, mechanical, flammability, etc

NOTE 3 - Licence number, file number or other documentary evidence of acceptance

Clause Requirement – Test Result - Remarks Verdict

5 MARKING AND DOCUMENTATION

5.1.1 General

Required equipment markings are:

visible:

From the exterior; or

After removing a cover; or

Opening a door

After removal from a rack or panel

Not put on parts which can be removed by an OPERATOR

Letter symbols (IEC 60027) used

Additional symbols cannot be confused with the

international ones

5.1.2 Identification

Equipment is identified by:

5.1.2a) Manufacturer’s name or trademark and address

5.1.2b) Model number, name or other means

5.1.2c) The name and address of the authorized representative of

the manufacturer

The equipment or packaging or the instructions for use

1) The serial-number or the batch code preceded by

„LOT“ symbol 102 of Table 1

2 i) Indication that the equipment is IVD medical equipment

2 ii) Indication that the equipment is self-test IVD medical

equipment

2 iii) Identification of detachable components

2 iv) Expiry date of consumable parts

5.1.3 Mains supply

Equipment is marked as follows:

5.1.3a) Nature of supply:

1) A.C. RATED mains frequency or range of frequencies

:

2) D.C with symbol 1

5.1.3b) RATED supply voltage(s) or range :

5.1.3c) Max RATED power (W or VA)or input current :

The measured value not more than 110 % (See Form A.3)

If more than one voltage range:

Separate values marked; or

Values differ by less than 20 % (See Form A.3)

5.1.3d) OPERATOR-set for different RATED supply voltages:

Indicates the equipment set voltage

PORTABLE EQUIPMENT indication is visible from the exterior

Changing the setting changes the indication

Clause Requirement – Test Result - Remarks Verdict

5.1.3e) Accessory mains socket-outlets accepting standard mains plugs

are marked:

With the voltage if it is different from the mains supply

voltage :

For use only with specific equipment

If not marked for specific equipment it is marked with:

The maximum RATED current or power; or

Symbol 14 with full details in the documentation

5.1.4 Fuses

OPERATOR replaceable fuse marking

(see also 5.4.5) :

5.1.5 T ERMINALS , connections and operating devices

Where necessary for safety, indication of purpose of

TERMINALS, connectors, controls and indicators marked

If insufficient space, symbol 14 used

5.1.5.1 T ERMINALS

Mains supply TERMINALS identified

Other TERMINAL marking :

5.1.5.1a) FUNCTIONAL EARTH TERMINALS (symbol5 used)

5.1.5.1b) PROTECTIVE CONDUCTOR TERMINALS:

Symbol 6 is placed close to or on the TERMINAL; or

Part of appliance inlet

5.1.5.1c) TERMINALS of measuring and control circuits (symbol 7

used)

5.1.5.1d) HAZARDOUS LIVE TERMINALS supplied from the interior

Standard MAINS socket outlet; or

RATINGS marked; or

Symbol 14 used

5.1.5.1e) ACCESSIBLE FUNCTIONAL EARTH TERMINALS:

Self-evident; or

Indication (symbol 8 acceptable)

5.1.5.2 Measuring circuit TERMINALS

For TERMINALS other than those permanently connected and

not ACCESSIBLE:

RATED voltage or current marked

Unless clear indication that below limits:

Maximum RATED voltage to earth is marked; or

For specific connection to other equipment TERMINALS only, and

means for identifying provided

Appropriate measurement category marked

(CAT II, CAT III or CAT IV); or

No measurement category marked (CAT I)

Required markings are adjacent to TERMINALS; OR

If insufficient space:

On the RATING plate or scale plate; or

TERMINAL is marked with symbol 14

Clause Requirement – Test Result - Remarks Verdict

5.1.6 Switches and circuit breakers

If disconnecting device, on or off position marked

5.1.7 Equipment protected by DOUBLE INSULATION or

REINFORCED INSULATION

Protected throughout (symbol 11 used)

Only partially protected (symbol 11 not used)

5.1.8 Field-wiring TERMINAL boxes

If TERMINAL or ENCLOSURE exceeds 60 °C: (See 10.3a))

Cable temperature RATING marked

Marking visible or beside TERMINAL

5.1.101 Transport and storage

Packaging labelled to indicate special conditions for

transport or storage

5.2 Warning markings

Visible when ready for NORMAL USE

Are near or on applicable parts

Symbols and text correct dimensions and colour

If necessary marked with symbol 14

Statement to isolate or disconnect

Potentially infectious equipment marked with symbol 101

Equipment that can be hazardous due to the use of chemical

substances marked with the appropriate symbol

Containers or bags for biohazardous waste material which can be

removed from the equipment during NORMAL USE marked with

symbol 101

5.3 Durability of markings

The required markings resist the effects of temperature and

rubbing, and of solvent and reagents likely to be

encountered in NORMAL USE

(See Form A.4)

5.4 Documentation

5.4.1 General

Equipment is accompanied by documentation which

includes:

(For documents see Table 1)

5.4.1a) Intended use

5.4.1b) Technical specification

5.4.1c) Instructions for use

5.4.1d) Name and address of manufacturer or supplier

5.4.1e) Information specified in 5.4.2 to 5.4.5

5.4.1f) If marking of TERMINALS required, definition of measurement

Provided in the documentation; or

Information is marked on the equipment

Clause Requirement – Test Result - Remarks Verdict

Information about any RISKS not reduced to a TOLERABLE RISK

level

Information included in documentation on:

Training; or

Protective devices; or

Personal protective equipment to reduce RISKS to a

TOLERABLE RISK level specified;

5.4.2 Equipment RATINGS

Documentation includes:

5.4.2a) Supply voltage or voltage range

Frequency or frequency range

Power or current RATING

5.4.2b) Description of all input and output connections

5.4.2c) RATING of insulation of external circuits,

when such circuits are nowhere ACCESSIBLE

5.4.2d) Statement of the range of environmental conditions

5.4.2e) Degree of protection (IEC 60529)

5.4.3 Equipment transportation, installation and assembly

instructions

—Documentation for the RESPONSIBLE BODY includes : —

5.4.3a) Instructions for transportation after delivery to the RESPONSIBLE

BODY

5.4.3b) Floor loading requirements

5.4.3c) Individual weights of principal heavy subassemblies

5.4.3d) Location and mounting instructions

5.4.3e) Assembly instructions

5.4.3f) Instructions for protective earthing

5.4.3g) The sound data required by 12.5.1

5.4.3h) Instructions relating to handling, containment and exhaust of

hazardous substances

5.4.3I) Any drainage systems required

5.4.3j) Protective measures relating to hazardous radiation

5.4.3k) Connections to the supply

1) Mains supply requirements and details of connections

2) If external switch or circuit-breaker, requirements and location

recommendation

5.4.3m) Special services including pressure limits

5.4.4 Equipment operation

Instructions for use include:

5.4.4a) Details of operating controls

5.4.4b) Positioning for disconnection

5.4.4c) Interconnection

5.4.4d) Specification of intermittent operation limits

5.4.4e) Explanation of symbols used

Clause Requirement – Test Result - Remarks Verdict

5.4.4f) Any actions by an OPERATOR in case of a malfunction

5.4.4g) Cleaning and decontamination (see 11.2) incl materials

5.4.4h) Disposal of waste

5.4.4i) Hazardous substances,use, need for training,or personal

protection measures

5.4.4j) Infectious substances, need to use protective gloves or

other protective means

5.4.4k) Hazardous vapours, instructions for protection of the

mouth, nose or eyes

5.4.4l) Hazardous radiation, instructions and requirements for

protective devices

5.4.4m) A statement about protection impairment if used in a

manner not specified by the manufacturer

5.4.4.101 Self-test IVD medical equipment

Instructions for use for self-test equipment comply with

annex BB

5.4.5 Equipment maintenance

Instructions include:

Sufficient preventive maintenance and inspection information

Replacement of hoses, etc

Specific battery type

Any manufacturer specified parts

RATING and characteristics of fuses

5.4.101 Removal of equipment from use for repair or disposal —

Instructions for the RESPONSIBLE BODY for eliminating or

reducing HAZARDS provided

Permissible environmental conditions for transport and

ACCESSIBLE parts not HAZADOUS LIVE in NORMAL CONDITION

and SINGLE FAULT CONDITION

Conformity is checked by the determination of 6.2 and 6.3

followed by the tests of 6.4 to 6.11

6.1.2 Exceptions

Capacitance test (See Forms A.6 and A.7)

Parts not HAZARDOUS LIVE 10 s after interruption of supply

6.2 Determination of ACCESSIBLE parts (See Form A.6)

6.2.1 General examination

6.2.2 Openings above parts that are HAZARDOUS LIVE

6.2.3 Openings for pre-set controls

6.3 Permissible limits for ACCESSIBLE parts

6.3.1 Values in NORMAL CONDITION (See Form A.7)

Clause Requirement – Test Result - Remarks Verdict

6.3.2 Values in SINGLE FAULT CONDITION (See Form A.8)

6.4 Protection in NORMAL CONDITION

(see 6.2, 6.3.1, 6.7, 6.8 and 8.1)

6.5 Protection in SINGLE FAULT CONDITION

Additional protection is provided by:

One or more of 6.5.1 to 6.5.3; or

Automatic disconnection of the supply (6.5.4)

6.5.1 Protective BONDING

ACCESSIBLE conductive parts:

Separated by DOUBLE INSULATION or REINFORCED INSULATION; or

Bonded to the PROTECTIVE CONDUCTOR TERMINAL; or

Separated by screen or BARRIER bonded to PROTECTIVE

CONDUCTOR TERMINAL from parts which are HAZARDOUS LIVE

6.5.1.1 Integrity of PROTECTIVE BONDING

6.5.1.1a) PROTECTIVE BONDING consists of directly connected

structural parts or discrete conductors or both; and

withstands thermal and dynamic stresses

6.5.1.1b) Soldered connections:

Independently secured

Not used for other purposes

Screw connections are secured

6.5.1.1c) PROTECTIVE BONDING not interrupted

6.5.1.1d) Any moveable connection specifically designed, and meets

6.5.1.3

6.5.1.1e) No external metal braid of cables used

6.5.1.1f) If MAINS supply passes through:

Means provided for passing protective conductor;

2) internal protective conductors etc.;

Green/yellow not used for other purposes

6.5.1.1h) TERMINAL suitable, and meets 6.5.1.2

6.5.1.2 P ROTECTIVE CONDUCTOR TERMINAL

6.5.1.2a) Contact surfaces are metal

6.5.1.2b) Appliance inlet used

6.5.1.2c) For rewireable cords and PERMANENTLY CONNECTED

EQUIPMENT, PROTECTIVE CONDUCTOR TERMINAL is close to

MAINS supply TERMINALS

6.5.1.2d) If no MAINS supply is required, any PROTECTIVE CONDUCTOR

TERMINAL:

Is near TERMINALS of circuit for which protective earthing is

necessary

External if other TERMINALS external

6.5.1.2e) Equivalent current-carrying capacity to MAINS supply

TERMINALS

Clause Requirement – Test Result - Remarks Verdict

6.5.1.2f) If plug-in, makes first and breaks last

6.5.1.2g) If also used for other bonding purposes, protective

conductor:

Applied first;

Secured independently;

Unlikely to be removed by servicing; or

Warning marking requires replacement of protective

Indirect bonding used (see 6.5.1.5)

6.5.1.2i) FUNCTIONAL EARTH TERMINALS allow independent connection

6.5.1.2j) If a binding screw:

Suitable size for bond wire

Not smaller than M 4 (No 6)

At least 3 turns of screw engaged

Contact pressure not capable of reduction by deformation

of materials

Passes tightening torque test (See Form A.9)

6.5.1.3 Impedance of PROTECTIVE BONDING of plug-connected

6.5.1.4 Bonding impedance of PERMANENTLY CONNECTED

EQUIPMENT

(See Form A.10)

6.5.1.5 Indirect bonding for measuring and test equipment (See Form A.11)

6.5.2 DOUBLE INSULATION and REINFORCED INSULATION

(see 6.7, 6.8 and 6.9.2)

6.5.3a) HIGH-INTEGRITY single component used (s 14.6); or

6.5.3b) A combination of components used; or

6.5.3c) A combination of BASIC INSULATION and current- or

voltage-limiting device used

Components, wires and connections are RATED as required

6.5.4 Automatic disconnection of the supply

If used, it meets :

6.5.4a) Supplied with the equipment; or

Specified by installation instruction

6.5.4b) RATED disconnecting time within limit specified

6.5.4c) RATED for maximum RATED LOAD

6.6 Connections to external circuits

6.6.1 General

Connections do not cause ACCESSIBLE parts of the following

to become HAZARDOUS LIVE in NORMAL CONDITION or SINGLE

FAULT CONDITION:

6.6.1a) The external circuits

Clause Requirement – Test Result - Remarks Verdict

6.6.1b) The equipment

Separation of circuits provided; or

Short circuit of separation does not cause a HAZARD

1) RATED conditions for TERMINAL

2) Required RATING of external circuit insulation

6.6.2 TERMINALS for external circuits

TERMINALS which receive a charge from an internal

capacitor are not HAZARDOUS LIVE

(See Form A.7)High voltage TERMINALS energized from the interior are:

Not ACCESSIBLE or

When unmated, no HAZARDOUS LIVE voltage; or

marked with symbol 12

6.6.3 Circuits with TERMINALS which are HAZARDOUS LIVE

These circuits are:

Not connected to ACCESSIBLE conductive parts; or

Connected to ACCESSIBLE conductive parts, but are not MAINS

CIRCUITS and have one TERMINAL contact at earth potential

No ACCESSIBLE conductive parts are HAZARDOUS LIVE

6.6.4 A CCESSIBLE TERMINALS for stranded conductors

6.6.4a) No risk of accidental contact because:

Located or shielded

Self-evident or marked whether connected to ACCESSIBLE

conductive parts

6.6.4b) ACCESSIBLE TERMINALS will not work loose

6.7 CLEARANCES and CREEPAGE DISTANCES (See Form A.5 and A.13)

6.8 Procedure for dielectric strength tests (See Form A.5 and A.14)

6.9 Constructional requirements for protection

against electric shock

6.9.1 General

If a failure could cause a HAZARD:

6.9.1a) Security of wiring connections

6.9.1b) Screws securing removable covers

6.9.1c) Accidental loosening

Easily damaged materials not used

Non-impregnated hydroscopic materials not used

6.9.2 ENCLOSURES of equipment with DOUBLE INSULATION or

REINFORCED INSULATION

ENCLOSURE surrounds all metal parts except for small metal

parts which are separated

ENCLOSURES or parts made of insulating material

Protection for metal ENCLOSURES or parts by:

6.9.2a) An insulating coating or BARRIER on the inside; or

6.9.2b) CLEARANCES and CREEPAGE DISTANCES cannot be reduced by

loosening of parts or wires

Clause Requirement – Test Result - Remarks Verdict

6.9.3 Over-range indication

Unambiguous

6.10 Connection to MAINS supply source and connections

between parts of equipment

6.10.1 M AINS supply cords

6.10.1a) RATED for maximum equipment current (see 5.1.3c)

Cable complies with IEC 60227 or IEC 60245 or is a certified cord

6.10.1b) Heat-resistant if likely to contact hot parts

6.10.1c) Temperature RATING (cord and inlet)

6.10.1d) Green/yellow used only for connection to PROTECTIVE

CONDUCTOR TERMINALS

Detachable cords with IEC 60320 MAINS connectors:

Conform to IEC 60799; or

Have the current RATING of the MAINS connector

6.10.2 Fitting of non-detachable MAINS supply cords

Non-detachable cord protection:

6.10.2a) Inlet or bushing smoothly rounded; or

6.10.2b) Insulated cord guard protruding ≥ 5D

The protective earth conductor is the last to take the strain

6.10.2 Cord anchorages:

6.10.2a) Cord is not clamped by direct pressure from a screw

6.10.2b) Knots are not used

6.10.2c) Cannot push the cord into the equipment to cause a HAZARD

6.10.2d) No failure of cord insulation in anchorage with metal parts

6.10.2e) Compression bushing:

Clamps all types and sizes of MAINS cords; and Is suitable for

connection to TERMINALS provided; or

:

It is designed for a specified screened MAINS cord

6.10.2f) Cord replacement does not cause a HAZARD and method of strain

relief is clear

6.10.3 Plugs and connectors

6.10.3a) MAINS supply plugs, connectors etc., conform with relevant

MAINS-type plugs used only for connection to MAINS supply

6.10.3c) Plug pins which receive a charge from an internal capacitor (See Form A.7)

6.10.3d) Accessory MAINS socket outlets:

1) Marking if accepts a standard MAINS plug

(see 5.1.3e)

2) Input has a protective earth conductorif outlet has earth

TERMINAL contact

Clause Requirement – Test Result - Remarks Verdict

6.11 Disconnection from supply source

6.11.1 General (see 6.11.1.1 to 6.11.2.6)

Disconnects all current carrying conductors

6.11.1.1 Exceptions

6.11.1.1a) Equipment supplied by low energy source; or

6.11.1.1b) Equipment connected to impedance protected supply; or

6.11.1.1c) Equipment constitutes an impedance protected load

6.11.2 Requirements according to type of equipment

6.11.2.1 P ERMANENTLY CONNECTED EQUIPMENT and multi-phase

equipment

Employs switch or circuit-breaker

If switch or circuit-breaker is not part of the equipment,

6.11.2.2 Single-phase cord-connected equipment

Equipment is provided with:

6.11.2.2a) Switch or circuit-breaker; or

6.11.2.2b) Appliance coupler (disconnectable without TOOL); or

6.11.2.2c) Separable plug (without locking device)

6.11.2.3 H AZARDS arising from function

Emergency switch

Emergency switch ≤ 1 m from the moving part

6.11.3 Disconnecting devices

Electrically close to the supply

6.11.3.1 Switches and circuit-breakers

When used as disconnection device:

Meets IEC 60947-1 and IEC 60947-3

Marked to indicate function

Not incorporated in MAINS cord

Does not interrupt protective earth conductor

If has other contacts meets separation requirements of 6.6

and 6.7

6.11.3.2 Appliance couplers and plugs

Where an appliance coupler or separable plug is used as

the disconnecting device (see 6.11.2.2):

Readily identifiable and easily reached by the OPERATOR

Single-phase PORTABLE EQUIPMENT cord

length ≤ 3 m

Protective earth conductor connected first and

disconnected last

Clause Requirement – Test Result - Remarks Verdict

7 PROTECTION AGAINST MECHANICAL HAZARDS

If OPERATOR access permitted:

a) Access requires TOOL

b) Statement about training

c) Warning markings or symbol 14

7.3 Stability

Marking of non-automatic means

Conformity tests:

7.3a) 10° tilt test

7.3b) multi-directional force test

7.3c) downward force test

7.4 Provisions for lifting and carrying

Handles or grips withstand four times weight

Equipment contains or limits the energy

Protection not removable without the aid of a TOOL

8 MECHANICAL RESISTANCE TO SHOCK AND IMPACT

After the tests of 8.1 to 8.2:

Inspections:

8a) HAZARDOUS LIVE parts not accessible

8b) ENCLOSURE shows no cracks (HAZARD)

8c) CLEARANCES not less than their permitted values (See Form A.13)

8d) BARRIERS not damaged or loosened

8e) No moving parts exposed, except permitted by 7.2

8f) No damage which could cause spread of fire

8.1 E NCLOSURE rigidity test (See Form A.15)

Records of tests performed by the manufacturer show

conformity

( See test records attached)

Clause Requirement – Test Result - Remarks Verdict

9 PROTECTION AGAINST THE SPREAD OF FIRE

Conformity for each source of HAZARD or area of the

equipment is checked by one of the following:

(See Form A.17)

9a) Fault test of 4.4; or (See Forms A.1 and A.2)

9b) Application of 9.1 (eliminating or reducing the sources of

ignition); or

9c) Application of 9.2 (containment of fire within the equipment)

9.1 Eliminating or reducing the sources of ignition within

the equipment

9.1a) 1) Limited-energy circuit (see 9.3); or

2) Insulation meets the requirements for BASIC INSULATION; or (See Form A.5 and A.14)

Bridging the insulation does not cause ignition (See Form A.2)

9.1b) Surface temperature of liquids and parts (see 9.4.a)

9.1c) No ignition in circuits designed to produce heat (See Form A.2)

9.2 Containment of the fire within the equipment, should it

9.2.1a) Insulated wires have flammability classification FV1 or

Connectors and insulating material have flammability

classification FV2 or better

(See Table 3 or Form A.18)

9.2.1b) The ENCLOSURE is constructed as follows : (See Form A.17)

1) Bottom constructed with:

No openings; or

Extent as specified in figure 7; or

Baffles as specified in figure 6; or

Perforated as specified in table 12; or

Metal screen with a mesh

2) Sides have no openings as specified in figure 7

3) Material of ENCLOSURE and any baffle or flame BARRIER

is made of……… :

Metal (except magnesium); or

Non metallic materials have flammability classification FV1

or better

(See Table 3 or Form A.18)

4) ENCLOSURE and any baffle or flame BARRIER have

2) Overcurrent protective device; or

Clause Requirement – Test Result - Remarks Verdict

3) A regulating network limits also in SINGLE FAULT

CONDITION

9.3c) Is separated by at least BASIC INSULATION

If Overcurrent protective device used:

Fuse or a non adjustable electromechanical device

9.4 Requirements for equipment containing or using

flammable liquids

Flammable liquids contained in or specified for use with

equipment do not cause spread of fire

Risk is reduced to a tolerable level : (See Form A.20)

9.4a) The temperature of surface or parts in contact with

flammable liquids is 25 °C below fire point (See 10.3b))

9.4b) The quantity of liquid is limited

9.4c) Flames are contained within the equipment

Detailed instructions for risk-reduction provided

9.5 Overcurrent protection

Devices not in the protective conductor

Fuses or single-pole circuit-breakers not fitted

in neutral (multi-phase)

9.5.1 PERMANENTLY CONNECTED EQUIPMENT

Overcurrent device:

Fitted within the equipment; or

Specified in manufacturer's instructions

9.5.2 Other equipment

Protection within the equipment

10 EQUIPMENT TEMPERATURE LIMITS AND RESISTANCE

TO HEAT

10.1 Surface temperature limits for protection against burns

Easily touched surfaces within the limits (See Form A.21A)

Heated surfaces necessary for functional reasons

exceeding specified values:

Are recognizable as such by appearance or function; or

Are marked with symbol 13

Guards are not removable without TOOL

10.2 Temperatures of windings (See Form A.21B)

Limits not exceeded in:

NORMAL CONDITION

SINGLE FAULT CONDITION

10.3 Other temperature measurements (See Form A.21A)

Following measurements conducted if applicable:

10.3a) Value of 60 °C of field-wiring TERMINAL box not exceeded

10.3b) Surface of flammable liquids and parts in contact with this

liquids

10.3c) Surface of non-metallic ENCLOSURES

10.3d) Parts made of insulating material supporting parts

connected to MAINS supply

10.3e) TERMINALS carrying a current more than 0.5 A

Clause Requirement – Test Result - Remarks Verdict

10.4 Conduct of temperature test

10.5 Resistance to heat

10.5.1 Integrity of CLEARANCE and CREEPAGE

DISTANCES

(See Form A.13)

10.5.2 Non-metallic ENCLOSURES (See Forms A.22)

After treatment:

No HAZARDOUS LIVE parts ACCESSIBLE;

Tests of 8.1 and 8.2 (See Form A.13)

In case of doubt, tests of 6.8

(without humidity preconditioning)

(See Form A.14)

10.5.3 Insulating material

10.5.3a) Parts supporting parts connected to MAINS supply (See 10.3d))

10.5.3b) TERMINALS carrying a current more than 0.5 A (See 10.3e))

In case of doubt, examination of material data

If not conclusive:,

1) Ball pressure test; or (See Form A.23)

2) Vicat softening test of ISO 306 (See Form A.23)

11 PROTECTION AGAINST HAZARDS FROM FLUIDS

11.1 General

Potentially aggressive substances (such as corrosive, toxic

or flammable liquids) taken into account

Potentially aggressive substances compatible with

contacted parts of the equipment

11.5 Battery electrolyte

Battery electrolyte leakage presents no hazard

11.6 Specially protected equipment (See Form A.24)

11.7 Fluid pressure and leakage

11.7.1 Maximum pressure

Maximum pressure of any part does not exceed PRAT ED

11.7.2 Leakage and rupture at high pressure (See Form A.25)

Test to IEC 60335 (refrigeration only)

11.7.3 Leakage from low-pressure parts (See Form A.25)

11.7.4 Overpressure safety device

Does not operate in NORMAL USE

Meets ISO 4126-1; and

It conforms with:

11.7.4a) Connected as close as possible to parts intended to be protected

11.7.4b) Easy access for inspection, maintenance and repair

11.7.4c) Adjustment only with TOOL

11.7.4d) No discharge towards person

11.7.4e) No HAZARD from deposit of discharged material

11.7.4f) Adequate discharge capacity

Clause Requirement – Test Result - Remarks Verdict

11.7.4g) No shut-off valve between overpressure safety device and

protected parts

12 PROTECTION AGAINST RADIATION, INCLUDING LASER

SOURCES, AND AGAINST SONIC AND ULTRASONIC

PRESSURE

12.1 General

Equipment provides protection

12.2 Equipment producing ionizing radiation

12.2.2 Accelerated electrons

12.3 Ultra-violet (UV) radiation (Conformity test under

consideration)

12.4 Micro-wave radiation

Power density does not exceed 10 W/m2 :

12.5 Sonic and ultrasonic pressure

12.6 Laser sources (IEC 60825-1)

13 PROTECTION AGAINST LIBERATED GASES AND

SUBSTANCES, EXPLOSION AND IMPLOSION

13.1 Poisonous and injurious gases and substances

Attached data/test reports demonstrate conformity (in NC

and SFC)

(See Form A.1)

Dangerous amounts of poisonous or injurious gases or

substances not liberated in NORMAL CONDITION or in SINGLE

FAULT CONDITION

Attach any data/test reports used

to demonstrate conformity

If potentially hazardous substances are liberated: —

OPERATOR not be wetted nor able to inhale quantities likely

to be hazardous

protective covers or similar means of protection

13 PROTECTION AGAINST LIBERATED GASES,

EXPLOSION AND IMPLOSION

13.1 Poisonous and injurious gases

Attached data/test reports demonstrate conformity

13.2 Explosion and implosion

13.2.1 Components

Components liable to explode:

Pressure release device provided; or

Apparatus incorporates OPERATOR

protection (see also 7.6)

Pressure release device:

Discharge without danger

Cannot be obstructed

13.2.2 Batteries and battery charging

If explosion or fire HAZARD could occur:

Protection incorporated in the equipment; or

Instructions specify batteries with built-in protection

If wrong type of battery used:

Clause Requirement – Test Result - Remarks Verdict

No HAZARD; or

Warning by marking and in instructions

Equipment with means to charge rechargeable batteries:

Warning against the charging of non-rechargeable

batteries; and

Type of rechargeable battery indicated; or

Symbol 14 used

Battery compartment design, no fire or explosive HAZARD

Single component failure (See Form A.28)

Polarity reversal test (See Form A.28)

13.2.3 Implosion of cathode ray tubes

If maximum face dimensions > 160 mm :

Intrinsically protected and correctly mounted; or

ENCLOSURE provides protection

If non-intrinsically protected:

Screen not removable without TOOL

If glass screen, not in contact with surface of tube

13.2.4 Equipment RATED for high pressure (See 11.7)

Does not present a HAZARD when stopped or prevented f

Protected by overtemperature or thermal protection device

conform with 14.3

14.2.2 Series excitation motors

Connected direct to device, if overspeeding causes a

HAZARD

14.3 Overtemperature protection devices (See Form A.29)

14.3a) Reliable function is ensured

14.3b) RATED to interrupt maximum current and voltage

14.3c) Does not operate in NORMAL USE

Non-self resetting in self-test IVD equipment

14.4 Fuse holders

No access to HAZARDOUS LIVE parts

14.5 Mains voltage selecting devices

Accidental change not possible

14.6 HIGH INTEGRITY components

Used in applicable positions (See Table 3)

Conforms with IEC publications

Single electronic device not used

14.7 Mains transformers tested outside equipment (See Forms A.30 and A.31)

Clause Requirement – Test Result - Remarks Verdict

14.8 Printed circuit boards

Data shows conformity with FV-1 of IEC 60707 or better; or

Test shows conformity with FV-1 of IEC 60707 or better; or See Form A.18

Thin film flexible PCB with limited-energy circuit used

14.9 Circuits or components used as transient overvoltage

limiting devices

After test, no sign of overload or degradation

15 PROTECTION BY INTERLOCKS

15.1 General

Interlocks are designed to remove a hazard

before OPERATOR exposed

15.2 Prevention of reactivation

15.3 Reliability

Single fault unlikely to occur; or

Cannot cause a HAZARD

16 TEST AND MEASUREMENT EQUIPMENT

16.1 Current measuring circuits (See Form A.32)

16.2 Multifunction meters and similar equipment (See Form A.33)

No HAZARD from:

RATED input voltage combinations

Settings of functions

Settings of range controls

ANNEX F ROUTINE TESTS

Manufacturer’s declaration

ANNEX AA RISK management

Conformity demonstrated (See document attached)

ANNEX BB Instructions for use for self-test IVD medical equipment

Instructions comply

4.4.2 TABLE: Summary of SINGLE FAULT CONDITIONS Form A.1

apply Carried out

Comments 4.4.2.1 PROTECTIVE IMPEDANCE

4.4.2.2 Protective conductor

4.4.2.3 Equipment or parts for

short-term or inshort-termittent operation

4.4.2.4 Motors

4.4.2.5 Capacitors

4.4.2.6 Mains transformers

showing all protective devices (see Forms A.29 and A.30)

4.4.2.7 Outputs

4.4.2.8 Equipment for more than one

supply

4.4.2.9 Cooling (see note)

– air holes closed – fans stopped – coolant stopped

4.4.2.10 Heating devices (see note)

– timer overridden – temperature controller overridden

– loss of cooling liquid – overfilled or empty or both

4.4.2.11 Insulation between circuits and

parts

4.4.2.12 Interlocks

4.4.2.101 Incorrect voltage selection

List below all SINGLE FAULT CONDITIONS not covered by 4.4.2.1 to 4.4.2.101:

and substances

NOTE – Record surface temperatures of flammable liquids and parts in contact with them in Form A.20A

Supplementary information:

See Form A.2 for details of tests.

NOTE Td = Test duration in h:min:s

Record dielectric strength test on Form A.14 and temperature tests on Form A.21A or 21B

Record in the comments column for each test whether carried out during or after SINGLE FAULT CONDITION

5.1.3c) TABLE: Mains supply Form A.3

5.3 TABLE: Durability of markings Form A.4

Marking method (see note) Test Agent

NOTE – Where applicable include print method, label material, ink or

paint type, fixing method, adhesive and surface to which marking is

Switches and circuit breakers (5.1.6)

DOUBLE/REINFORCED equipment (5.1.7)

Warning marking (5.2)

Battery charging (13.2.2)

Method Test

agent Remains legible Label loose Curled edges Comments

Verdict Verdict Verdict

TABLE: Protection against electric shock - Block diagram of system Form A.5

Maximum working Voltage (note 2) PWB mm CTI Other mm CTI

CLEARANCE

(note 3) mm

Test voltage (note 2) V Comments

NOTE 1 – Type of insulation:

6.2 TABLE: List of ACCESSIBLE parts Form A.6

6.1.2 Exceptions

6.2 Determination of accessible parts

Item Description Determination method

(note 5)

Exception under 6.1.2

(note 4)

NOTE 1 – Test fingers and pins are to be applied without force unless a force is specified (see 6.2.1)

NOTE 2 – Special consideration should be given to inadequate insulation and high voltage parts (see 6.2)

NOTE 3 – Parts are considered to be ACCESSIBLE if they could be touched in the absence of any covering which is not

considered to provide suitable insulation (see note to paragraph 1 of 6.4)

NOTE 4 – Capacitor test may be required (see Form A.7)

NOTE 5 – The determination methods are: visual; rigid test finger; jointed test finger; pin 3 mm diameter; pin 4 mm diameter

Supplementary information

NOTE 1 – The requirements of 6.3.1 include drying out (if specified) For PERMANENTLY CONNECTED EQUIPMENT, the current values are 1,5 times the specified values.

NOTE 2 – A 5 s test is specified in 6.10.3c)

Comments

NOTE – Transient voltages must be below the limits given from Figure 1 and the capacitance below the limits from Figure 2 of IEC 61010-1

6.5.1.2 TABLE: PROTECTIVE CONDUCTOR TERMINAL - Tightening torque test Form A.9

Location Size of Screw Tightening

torque Nm

Verdict

6.5.1.3 TABLE: Bonding impedance of plug connected equipment Form A.10

ACCESSIBLE part under test

Test current A

Voltage attained after 1 min V

Calculated resistance (maximum allowed 0,1 )

Ω

Verdict

Supplementary information:

6.5.1.4 TABLE: Bonding impedance of PERMANENTLY CONNECTED EQUIPMENT

ACCESSIBLE part under test current Test